Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)

K-Number: K242789 · 2025-01-02

ApplicantDongguan Laiguang Electronic Technology Co., Ltd.
Decision Date2025-01-02
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) is a medical device manufactured by Dongguan Laiguang Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-02 under approval number K242789. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)?

Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) is a medical device that received FDA 510(k) clearance on 2025-01-02. It is manufactured by Dongguan Laiguang Electronic Technology Co., Ltd.. The 510(k) number is K242789.

When was Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) approved by the FDA?

Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) received FDA 510(k) clearance on 2025-01-02, under approval number K242789.

What company makes Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)?

Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) is manufactured by Dongguan Laiguang Electronic Technology Co., Ltd..

What is the FDA product code for Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)?

The FDA product code for Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) is OHS.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07615569 Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07611643 Bruxism Therapy of Facial Pain RECRUITING

Related PubMed Literature

PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑